From PDUFA Dates to Phase Data — We Track What Moves the Stock
We track every PDUFA date, clinical trial readout, and FDA advisory committee meeting. We break down what the science means in plain English — no PhD required. If it moves a biotech stock, we're on it.
See the FDA Calendar →Madrigal Pharmaceuticals faces an August 14 PDUFA date for resmetirom — the first-ever drug for MASH/NASH. A 30-year hunt for a fatty liver disease treatment comes down to one FDA decision.
Vertex Pharmaceuticals' suzetrigine (VX-548) has an August 30 PDUFA date. If approved, it would be the first new class of acute pain medication in 25 years — and the first non-opioid to match opioid efficacy.
Moderna's personalized cancer vaccine (mRNA-4157, combined with Keytruda) showed a 44% reduction in recurrence-free survival in melanoma. Phase 3 is underway. An November 15 PDUFA could make it the first approved mRNA cancer vaccine.
FDA Calendar — PDUFA Dates, Advisory Panels, Trial Readouts
Checkpoint inhibitors, CAR-T cell therapies, and antibody-drug conjugates driving the next wave of approvals.
CRISPR, base editing, and AAV-delivered one-time treatments — binary risk, massive upside if they work.
Beyond COVID: mRNA platforms expanding into oncology, rare disease, and personalized vaccines.
Orphan drug designations, ultra-rare indications, and the pricing power that comes with tiny patient populations.
Alzheimer's, Parkinson's, and ALS — historically the graveyard of biotech, but new mechanisms are showing promise.
Vaccines, antivirals, and antibiotics. Pandemic preparedness funding is a new tailwind.